Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of obe2109 in subjects with endometriosis

Conditions: Endometriosis

Summary: the primary objective of this study is to assess the efficacy and safety of a range of oral doses of obe2109 versus placebo, in reducing endometriosis associated pain.

the study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of obe2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain. subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen). eligible subjects will be offered the opportunity to continue treatment with obe2109 in an extension phase. subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.

Eligibility criteria:
key inclusion criteria: * the subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening. * the subject has moderate to severe endometriosis-associated pain during the screening period. * the subject has regular menstrual cycles. * the subject has a bmi ≥ 18 kg/m2 at the screening visit. key exclusion criteria: * the subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study. * the subject had an interventional surgery for endometriosis performed within a period of 60 days before screening. * the subject did not respond to prior treatment with gonadotropin releasing hormone (gnrh) agonists or gnrh antagonists for endometriosis. * the subject has a history of, or known osteoporosis or other metabolic bone disease. * the subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.

Keywords: pelvic pain endometriosis dysmenorrhea dyspareunia
the effect of physical training and the omega 3 consumption on attention deficit hyperactivity disorder in children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the attention deficit hyperactivity disorder (adhd) usually occurs in preschool and may cause disabilities through whole life.

the attention deficit hyperactivity disorder (adhd) usually occurs in preschool and may cause disabilities through whole life. the treatment of this disease is expensive and difficult. moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. the aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of bdnf and igf-1 in adhd children. thus, 68 adhd children, between seven and fourteen years old will be selected. the volunteers will be randomly divided into four groups: physical training group (ptg), omega group (og), omega and physical training group (optg) and control group (cg). the protocol of the experiment will last three months in which the optg will make physical training and receive fish oil capsules, and the ptg will make only the physical training and receive a placebo of fish oil. the others groups will be oriented not to make any type of physical training, but the og will receive fish oil capsule, and the cg will receive a placebo of fish oil. behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.

Eligibility criteria:
inclusion criteria: * children with adhd: male, between seven and fourteen years old, sedentary, studing in a regular school. exclusion criteria: * taking psychoactive medications, taking omega supplement.

Keywords: physical training adhd-attention deficit hyperactivity disorder omega 3
effects of deep cervical flexors training on forward head posture, neck pain and functional status

Conditions: Forward Head Posture; Neck Pain

Summary: using computer for long hours is related to higher risk of computer related muscular disorders like forward head posture and neck pain. deep cervical flexor muscles are important head-on-neck posture stabilizers thus their training may lead to improvement in forward head posture (fhp) and neck pain (np).

in contemporary societies, computer use by children is a necessity and thus highly prevalent. using computer for long hours is related to higher risk of computer-related muscular disorders like forward head posture and neck pain. deep cervical flexor muscles are important head-on-neck posture stabilizers thus their training may lead to improvement in forward head posture (fhp) and neck pain (np). aim of study was to determine if 4 weeks of deep cervical flexors training is effective in alleviating neck pain and improving forward head posture in adolescent children using computer regularly. a pretest-posttest experimental group design was used. subjects were randomly assigned into control group (receiving postural advice only) and experimental group (receiving deep cervical flexor training and postural advice). dependent variables were measured on day 0 (at baseline) and after 4weeks of training. the photographic analysis was used for measuring forward head posture, visual analog scale (vas) for neck pain intensity and neck disability index (ndi) for functional disability. experimental group received craniocervical flexion training for 4 weeks and postural advice. control group received only postural advice.

Eligibility criteria:
inclusion criteria: * neck pain with or without headache, of duration more than 3 months and less than 1 year and 6 months, as identified by body discomfort chart and * neck disability index value less than 24 (mild to moderate disability scores on ndi) * forward head posture as identified by straight line down from external meatus falling anterior to shoulder and mid thorax. * using computer for at least 3 hours a day for at least 4 days a week or more. exclusion criteria: * ongoing or previous history of spinal fracture * ongoing or previous history of neurological signs * ongoing or previous history of inflammatory disease * ongoing or previous history of spinal tumor * ongoing or previous history of spinal infection * ongoing or previous history of spinal cord compression * ongoing or previous history of congenital, or acquired postural deformity * ongoing or previous history of cervical spinal surgery * ongoing or previous history of spinal instability

Keywords: neck pain forward head posture deep cervical flexors
pap for children with ds and osas

Conditions: Down Syndrome; Obstructive Sleep Apnea

Summary: determine the efficacy of family-informed intervention (int) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and down syndrome.

evaluate the effect of pap adherence on quality of life, neurobehavioral, and healthcare utilization in children with ds and osas. it is being hypothesized that, irrespective of study arm, increased pap adherence will be associated with better quality of life, neurobehavioral, and healthcare utilization outcomes. evaluate the effect of pap adherence in children with ds and osas on patient-centered outcomes and family-relevant outcomes identified during the r61 phase of this research. it is being hypothesized that irrespective of study arm, increased pap adherence will be associated with better patient-centered outcomes, and family-relevant outcomes identified during the first year of this research. determine the efficacy of int vs. con in promoting pap adherence. it is being hypothesized that that children receiving int will show significantly increased objectively-measured pap adherence at 6 months compared with those receiving con (aim 4a). as a secondary aim (4b), it will be evaluated whether the improved adherence is maintained over 12 months. it is being hypothesized that participants initially randomized to the int arm will have better adherence at 12 months compared to those in the con arm. use mixed methods during the randomized controlled trial to identify family perceptions, such as empowerment and self-efficacy, regarding pap use in youth with osas and ds. it is being hypothesized that int-pap will be associated with more positive perceptions compared to con.

Eligibility criteria:
inclusion criteria: * clinical referral for pap initiation to treat osas * ages 6-18 years * children are able to cooperate with testing * naive to pap treatment exclusion criteria: * major illnesses, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant. * family planning to move out of the city within the next year * children in foster care * child with previously treated with pap * caregivers who do not speak english well enough to complete behavioral and performance measures.

Keywords: down syndrome obstructive sleep apnea pap positive airway pressure
clinical evaluation of exodx prostate(intelliscore) in men presenting for initial prostate biopsy

Conditions: Urologic Cancer

Summary: the study described here is being conducted to prospectively confirm the performance of the exodx prostate gene expression assay in patients presenting for an initial prostate biopsy and support of ce-marking the test for a european union launch.


Eligibility criteria:
inclusion criteria: * clinical suspicion for prostate cancer * elevated prostate-specific antigen between 2.0-10 ng/ ml * scheduled for a initial prostate biopsy exclusion criteria: * clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment. * history of prostate cancer. * history of invasive treatments for benign prostatic hypertrophy (bph) or lower urinary track symptoms within 6 months of study enrollment. * known hepatitis status (all types) and/or hiv documented in patient's medical record. * patients with history of concurrent renal/bladder tumors. * prior mri used in the decision to biopsy

Keywords: exosome exodx prostate
oxygenation and pulmonary function in morbidly obese patients undergoing bariatric surgery

Conditions: Morbid Obesity

Summary: this is a randomized controlled study in which morbidly obese patients undergoing bariatric surgery will be recruited in the preoperative clinic. patients will be randomized into 2 groups to receive oxygen with boussignac tm continuous positive airway pressure (cpap) or conventional venturi mask postoperatively immediately after extubation. the objective of the study is to examine if boussignac tm cpap results in improved oxygenation versus venturi face mask when it is applied immediately after extubation in morbidly obese patients post bariatric surgery.


Eligibility criteria:
inclusion criteria: * patient aged between 18 to 75 years of age * american society of anesthesiologists' (asa) class i to iii * morbidly obese with a body mass index \> 35 kg/m2 * patients undergoing bariatric surgery exclusion criteria: * patient refusal * pre-existing cardiac failure, asthma, chronic obstructive pulmonary disease or interstitial pulmonary disease * systolic blood pressure less than 90 mmhg despite pharmacotherapy * hb \< 70 g/l * impaired gastric emptying * severe psychiatric disorder * language barrier

Keywords: bariatric surgery morbidly obese bmi >35 cpap venturi boussignac ventilation pulmonary function morbidly obese patients undergoing bariatric surgery
head and neck trauma registry, protocol id: 032.mbsi.2021.d

Conditions: Craniocerebral Trauma

Summary: this is a retrospective registry dataset of all adults who presented with cervical and/or skull base fractures or a subdural hematoma at methodist dallas medical center (mdmc) and had consults to the neurological surgery department beginning in january of 2016, and continuing until a statistically significant number of cases are obtained.

this is a retrospective registry dataset of all adults who presented with cervical and/or skull base fractures or a subdural hematoma at methodist dallas medical center (mdmc) and had consults to the neurological surgery department beginning in january of 2016, and continuing until a statistically significant number of cases are obtained. subjects will undergo no additional tests or procedures as part of this registry study. all patient data will be obtained from the patient's electronic health records of the hospital or clinic in a retrospective manner. the process for gathering the data will not influence treatment decisions. there will be no direct patient contact associated with inclusion in this registry study.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * presenting to mdmc with cervical and/or skull base fractures or those with subdural hematomas exclusion criteria: * do not meet the study inclusion criteria laid out in section 4.1. * vulnerable populations
eradication of prostate cancer using f-989

Conditions: Prostate Cancer

Summary: the purpose of this study is to confirm the findings of an early study with prostate cancer and to expand our knowledge of treating prostate cancer using f-989.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of prostate cancer * referred to the study by their treating physician exclusion criteria: - any type of treatment before starting study
laparoscopic reinforcement suture (lars) of duodenal stump a prospective single arm phase ii study

Conditions: Duodenal Stump Leak

Summary: until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. we already introduced a technique of laparoscopic reinforcement suture (lars) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. therefore, a prospective phase ii study was designed for safety of this technique.

as the results of recent prospective randomized controlled clinical trials, laparoscopic gastrectomy has been accepted by one of standard treatments for early gastric cancer in korea, japan and china. however, duodenal stump leakage remains one of the fetal complications after gastrectomy until now. the incidence of duodenal stump leakage is reportedly between 1.6% to 5% in billroth ii or roux en y reconstruction after gastrectomy for gastric cancer. according to a recent multicenter study, the laparoscopic approach increased the risk of duodenal stump leakage development comparing to open approach. until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. i already introduced a technique of laparoscopic reinforcement suture (lars) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. therefore, a prospective phase ii study was designed for safety of this technique.

Eligibility criteria:
inclusion criteria: * histologically proven gastric adenocarcinoma that were treated with laparoscopic distal or total gastrectomy and b-ii or roux en y reconstruction and age of above 19 years exclusion criteria: * history of previous abdominal surgery except cholecystectomy and would be performed combined abdominal surgery except cholecystectomy. and also patients with advanced gastric cancer with gastric outlet obstruction or cancer invasion to pylorus

Keywords: gastric cancer laparoscopic gastrectomy laparoscopic reinforcement suture (lars)
effects of action observation therapy and motor imagery administered during immobilization period after surgical fixation of distal radius

Conditions: Distal Radius Fracture

Summary: the goal of this trial is to verify the effectiveness of motor imagery and action observation training in subjects undergoing surgery for distal radius fracture fixation. the main question it aims to answer is: - can action observation and motor imagery training administered during immobilisation period improve functional outcome after distal radius fracture fixation? participants will be asked to perform hand dexterity test and grip and pinch strength evaluation subjects assigned to control group will follow standard care


Eligibility criteria:
inclusion criteria: * right handed subjects * subjects after surgical distal radius fracture fixation exclusion criteria: * concomitant fractures of upper limbs * pathological fractures * cognitive or psychiatric disorders * neurological or reumatici diseases
raltegravir insulin sensitivity study

Conditions: HIV Infections

Summary: the purpose of the study is to look at the effects of two different hiv medications on the body's response to insulin (a hormone that regulates blood sugar levels). this will be done using a method called the 'euglycaemic clamp' the study will also investigate the effects of these drugs on blood fats and on circulating markers in the blood stream related to blood vessels (vascular inflammation markers).

subjects will undergo four euglycaemic clamp procedures in order to determine the extent of glucose disposal. the first clamp will be performed prior to the commencement of the first study drug administration, the second one following two weeks of study drug, the third after a two week washout period, prior to commencement of second study drug administration and the fourth after two weeks of the second study drug

Eligibility criteria:
inclusion criteria: * subjects must have documented negative hiv serology by elisa and p24 antigen * subjects must be clinically well males aged between 18 to 60 years * fasting blood glucose, total cholesterol and triglycerides within normal limits * hepatic transaminases (ast and alt) ≤ 3 × upper limit of normal (uln) * adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dl) * serum amylase ≤ 1.5 × uln (subjects with serum amylase \> 1.5 × uln will remain eligible if pancreatic lipase is ≤ 1.5 × uln) * sexually active males must use condoms during the course of the study * life expectancy ≥ 1 year * willing and able to provide informed consent exclusion criteria: * subjects with a waist hip ratio \> 0.97 or bmi \> 28 kg/m2 will be excluded * acute or chronic hepatitis b infection (determined by positive hepatitis b surface antigen result at the screening visit) * acute or chronic hepatitis c infection (determined by positive hepatitis c antibody result at the screening visit) * other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension * receiving on-going therapy with any of the following: * metabolically active medications * any lipid-lowering medication * hormonal agents (oestrogens or androgens) * glucocorticoids * beta-blockers * thiazide diuretics * thyroid preparations * psychotropic agents * anabolic steroids * megestrol acetate

Keywords: raltegravir euglycaemic clamp healthy volunteer
thermal images on smartphones to diagnose bacterial pneumonia in children in pakistan

Conditions: Infections - Bacterial; Pneumonia - Bacterial

Summary: this is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the national institute of health (nich) in karachi, pakistan. participants will include both males and females as well as all races and ethnicities. participants will have thermal pictures of their chest taken by trained study staff using a smartphone and a flir one attachment. thermal images will be read by trained radiologists to determine if bacterial pneumonia is present. results of the thermal image will then be compared to the results of the chest x-ray. if additional images of the chest or other areas of suspected related infection are available, additional thermal images will be taken of the same location within 24 hours of the other image.


Eligibility criteria:
inclusion criteria: * 18 months or younger; * patient at nich hospital in karachi, pakistan; * had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia; * consent obtained from one parent exclusion criteria: * thermal image cannot be done within 24 hours of chest x-ray
post approval study of the commercially available u-motion ii+ acetabular system and utf reduced stem

Conditions: Osteoarthritis

Summary: this is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (tha) with the u-motion ii+ acetabular system and utf reduced stem.

this is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (tha) with the u-motion ii+ acetabular system and utf reduced stem. the acetabular and femoral components will be uncemented. study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study. it is anticipated that up to 200 subjects will be enrolled at up to 5 sites. the subjects will be evaluated at predetermined intervals: baseline, procedure/ discharge and 6 weeks, 3 months, 6 months, 12 months, and 24 months post treatment for primary analysis and annually up to 5 years for device survivorship. the estimated study duration from first enrollment through completion of the final report is expected to be approximately 7 years. this study will be conducted at up to 5 investigational sites in the united states with previous clinical research experience and with adequate population of orthopedic patients requiring primary total hip arthroplasty.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria to be considered for inclusion in the study. 1. subject is between 18 and 75 years of age 2. subject is indicated for a unilateral or bilateral total hip arthroplasty (tha) based on the approved labeling of the device 3. subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip 4. subject is willing and able to provide informed consent to participate in the study; 5. subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits; exclusion criteria: * subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or subject inclusion criteria.